NCT00745927

Brief Summary

It has been reported that carbon dioxide (CO2) insufflation can reduce patient pain and abdominal discomfort during and after colonoscopy. Its safety and efficacy during colonoscopy even under sedation has been already assessed in some earlier trials. Air insufflation is still the standard method, however, because of a lack of suitable equipment and continued technical improvement in colonoscopy. In laparoscopic surgery, CO2 insufflation is widely applied and safely used with the patient under general anesthesia. CO2 insufflation is also applied for CT colonography for reduction of discomfort during or after procedure.2 During endoscopic procedure for colorectal neoplasia resection, however, long procedural time may increase not only the degree of discomfort during and after the procedure but also the risk of perforation. In addition to laparoscopic surgery, CO2 insufflation has also been applied to other endoscopic procedures. Saito et al reported the application of CO2 insufflation in Endoscopic submucosal dissection (ESD) of colorectal neoplasia in a prospective study in which their average procedural time using CO2 insufflation was 90 minutes under conscious sedation with average of 5.6 mg of midazolam. When compared with control group using room air, statistically negligible difference of pCO2 was observed with significant difference in abdominal discomfort.6 Screening colonoscopy, which can be completed within 15 minutes if no lesion being detected, requires high screenee satisfaction so as to improve patient compliance. In the setting of colonoscopy after positive FOBT, the attendance rate for secondary colonoscopy was around 60 to 70 % according to the data demonstrated in previous RCT and population-based studies. With application of CO2 insufflation, further improvement of patient compliance can be anticipated. This study aims to investigate whether use of CO2 insufflations can reduce examinee discomfort in comparison with air.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 31, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 3, 2008

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

August 14, 2012

Status Verified

August 1, 2012

Enrollment Period

4.2 years

First QC Date

August 31, 2008

Last Update Submit

August 13, 2012

Conditions

Colorectal NeoplasmColorectal Cancer

Keywords

Colorectal neoplasmColorectal cancerScreening colonoscopyCO2 insufflationsColonoscopy

Outcome Measures

Primary Outcomes (1)

  • Degree of abdominal discomfort during and after colonoscopy

    0, 2, 8-10 hr

Secondary Outcomes (1)

  • Number of neoplasm detected

    At the time of colonoscopy

Study Arms (2)

Room air insufflations

NO INTERVENTION

Room air will be used for insufflations during colonoscopy

CO2 insufflations

ACTIVE COMPARATOR

CO2 will be used for insufflations during colonoscopy

Other: CO2 insufflations

Interventions

CO2 insufflationsOTHER

CO2 insufflations during whole procedure of colonoscopy

CO2 insufflations

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects who receive Screening colonoscopy or secondary colonoscopy

You may not qualify if:

  • Subjects who have COPD or cardiovascular diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Hsiu-Po Wang, MD

    National Taiwan University Hospital

    STUDY DIRECTOR

Central Study Contacts

Han-Mo Chiu, M.D

CONTACT

886-2-23123456hanmochiu@ntu.edu.tw

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
National Taiwan University Hospital

Study Record Dates

First Submitted

August 31, 2008

First Posted

September 3, 2008

Study Start

June 1, 2008

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

August 14, 2012

Record last verified: 2012-08

Locations

TW(1)